A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea

Exclusion Criteria

• •Subjects will be excluded if they meet the following criteria: BMI \>95th percentile for age, apnea hypopnea index (AHI) \<10 or \>50 on in-lab polysomnography (PSG), central or mixed apneas accounting for \>25% of the total AHI, any anatomic finding on physical exam or drug induced sleep endoscopy (DISE) that would compromise the performance of stimulation (e.g. concentric soft palate collapse), other medical conditions resulting in medical instability (e.g. congestive heart failure, recent open heart surgery, immunosuppression, or chronic lung disease or aspiration), presence of another medical condition requiring future magnetic resonance imaging (MRI), history of cholesteatoma, or patients with another implantable device which could interact unintentionally with the Inspire system.
• •Subjects in whom general anesthesia for a surgical procedure is contraindicated due to other medical illnesses or conditions will be excluded.
• •Subjects with a life expectancy \< 12 months will be excluded.
• •Subjects who are unable to communicate pain or discomfort to their caretaker/parent, based on parental or investigator assessment, will be excluded.
• •Subjects with a history of bleeding or clotting disorders and those on blood thinning or NSAID medications will be excluded from participation.
• •Subjects taking muscle relaxant medication will be excluded from participation.
• •Female subjects who are pregnant or plan to become pregnant during the study period will be excluded. All female subjects will undergo urine beta-HCG testing on the day of procedures requiring general anesthesia (DISE, implantation, and any other unanticipated surgical procedures related to implantation). Subjects who are positive will not undergo surgical implantation or procedures under general anesthesia.
• •Subjects deemed unfit for participation by investigators or any other reason will be excluded.